MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-10-04 for COBAS 6000 CORE 04745868001 manufactured by Roche Diagnostics.
[2237456]
The user experienced a washing needle blockage after a sample with high protein content was tested for total protein. Afterward, several samples were tested with insufficiently washed cuvettes. Testing for more than 100 patient samples with questionable results was repeated. Of the data provided, the results for 61 patient samples were erroneous. All data is included in the attachment to the medwatch. The initial results for all of the patient samples were reported outside the laboratory. No information was provided to determine if any patients were adversely affected. No reagent lot information was provided.
Patient Sequence No: 1, Text Type: D, B5
[9418187]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[21871384]
The investigation determined the erroneous results were due to the clogged washing (waste) needle. The cause for the clog could not be determined. No adverse events were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2011-05196 |
| MDR Report Key | 2273696 |
| Report Source | 01,05,06 |
| Date Received | 2011-10-04 |
| Date of Report | 2011-12-01 |
| Date of Event | 2011-08-25 |
| Date Mfgr Received | 2011-09-13 |
| Date Added to Maude | 2011-10-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS 6000 CORE |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | JGQ |
| Date Received | 2011-10-04 |
| Model Number | NA |
| Catalog Number | 04745868001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-04 |